Empowering Children and Research Participants

The involvement of minors in medicine—whether as patients or as research participants—tends to be seen in the context of their vulnerability. This often results in ethical analysis that puts undue focus on the need for “special” protection. For example, policy-makers or ethics review committee members may look at the informed consent process and, on the presumption that minors lack the capacity to consent, impose the condition that parents or guardians should be the ones to consent or not on their behalf.

Minors are a diverse population with varying decisional competencies, different levels of comprehension and risk-benefit appreciation, and hugely divergent or even contradictory interests. While we readily recognise and accept these differences, we do not usually find it easy to take them into account when we are dealing with minors as an aggregate—as when we refer to minors as a vulnerable population. Thus it is easy to make such presumptions as that the minors involved (or proposed to be involved) in a research study tend to make irrational decisions and need to be protected from themselves and their own decisions regarding research participation.

Against this backdrop, Babcock reminds us of the need to “be wary of unquestioningly valuing parental choice as it can cause medical, personal and familial harm while also disregarding the importance of children’s autonomy, regardless of how ‘limited’ or ‘incompetent’ it may be”. She takes us beyond the common concerns related to research involvement as she considers cases where a child may be considered too young to make life or death decisions. She gives the counter-example of a child who has been ill all her life and on that account, has a greater capacity to understand her own decision than she is ordinarily given credit for. She holds that it may be reasonable for minors who are “severely ill, probably have been for a long time, to have the opportunity to refuse treatment and have that decision respected” as “minors have an overarching ability and right to have a role in their medical decision-making, regardless of the severity of the situation”.

In the context of a bioethical regime that generally gives minors the opportunity to “assent” but not to consent on their own to participate in biomedical resarch, this is a radical position to take. Even when researchers and ethics committees recognise that the level of minors’ competence to consent grows to a sufficient level even before they reach the age of majority, they still have to comply with legal provisions that provide age-based threshholds for decision-making. While surrogate decision-makers are usually limited by considerations of the best interest of the minors for whom they decide, minors themselves still cannot decide on their own. They are not recognised to be solely and independently capable of determining what are truly in their best interests.

It is interesting to see how this general attitude plays out in treatment cases as opposed to research cases. Insofar as research is concerned, it would not be surprising to see minors able to have expressions of dissent recognised. On the assumption that research on minors can hardly be directly beneficial to participants, a disagreement between parents or guardians on the one hand and minors on the other, would be unlikely. Respect for a minor’s dissent would not present difficulties. A minor’s “overarching ability and right to have a role in their medical decision-making, regardless of the severity of the situation” earns respect, but perhaps only because it proves to be consistent with the parents’ or guardians’ assessment of what is needed to protect the child from possible harm.

On the other hand, dissent by a minor to a clinical intervention that prolongs life is likely to come into conflict with a parental decision to continue medication. It is in these situations that respect for a minor’s autonomy truly gets tested, and parents or guardians can clarify the extent of their respect for a minor’s autonomy in medical decision-making. Babcock is not saying that minors should be allowed to make decisions on their own. What...